Efimosfermin alfa for F2- or F3-stage MASH
This study is testing a drug called efimosfermin alfa for people with MASH (Metabolic Dysfunction-Associated Steatohepatitis), a type of fatty liver disease, who have moderate to severe liver scarring (fibrosis, F2 or F3 stage). The goal is to see if efimosfermin alfa can help resolve the liver inflammation and damage, and improve long-term liver health, compared to a placebo (an inactive substance). Researchers will look for improvements in liver scarring and resolution of steatohepatitis after 52 weeks. They will also track liver-related health outcomes for up to 48 months. The study aims to enroll 1200 participants aged 18 to 75 years old who have MASH and at least two components of metabolic syndrome.
- Study design
- This is an interventional study comparing efimosfermin alfa to a placebo. It plans to enroll 1200 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for liver-related clinical outcomes for up to 48 months after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
At a glance
Conditions
NCT07221227
Where you'd take part
This study runs at 91 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
GSK Investigational Site
Chandler, Arizonastudy coordinator listed
Recruiting
GSK Investigational Site
Tucson, Arizonastudy coordinator listed
Recruiting
GSK Investigational Site
Little Rock, Arkansasstudy coordinator listed
Recruiting
GSK Investigational Site
Arcadia, Californiastudy coordinator listed
Recruiting
GSK Investigational Site
Covina, Californiastudy coordinator listed
Recruiting
GSK Investigational Site
Folsom, Californiastudy coordinator listed
Recruiting
GSK Investigational Site
Los Angeles, Californiastudy coordinator listed
Recruiting
GSK Investigational Site
Montclair, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Proportion of participants experiencing improvement in fibrosis by >=1 stage and no worsening of steatohepatitis at Week 52At Week 52
Proportion of participants experiencing improvement in fibrosis of greater than or equal to (\>=) 1 stage by MASH clinical research network (CRN) fibrosis scores and no worsening of steatohepatitis (defined as no increase in nonalcoholic fatty liver disease activity score \[NAS\] for ballooning, inflammation, or steatosis) at 52 weeks will be assessed. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity. NAS score ranges from 0 to 8, higher score indicates worse disease activity.
- Proportion of participants experiencing resolution of steatohepatitis reading and no worsening of MASH CRN fibrosis score at Week 52At Week 52
Resolution of steatohepatitis is defined as absence of fatty liver disease or isolated or simple steatosis without steatohepatitis and a NAS of 0 or 1 for inflammation, 0 for ballooning, and any value for steatosis. NAS score ranges from 0 to 8, higher score indicates worse disease activity. MASH CRN fibrosis score ranges from 0 to 4, higher score indicates greater severity.
- Time from randomization to an adjudicated composite liver-related clinical outcomeFrom Randomization (Day 1) to 48 months
Liver-related outcome will comprised of all-cause mortality; transplantation; occurrence of significant hepatic events.